Ear visualization system

ABSTRACT

An ear endoscope device for use in a surgical procedure in an ear includes a handle, a visualization shaft extending from the handle, a tool guide extending from the handle parallel to the visualization shaft and configured to guide a tool into the ear with the visualization shaft, an imaging sensor at a distal end of the visualization shaft, and a light source. In some embodiments, the ear endoscope is combined with a suction device. In other embodiments, it may be combined with another tool.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 62/533,192, filed Jul. 17, 2017, entitled, “EAR SURGERYVISUALIZATION DEVICE.” The disclosure of this priority application ishereby incorporated by reference in its entirety into the presentapplication.

BACKGROUND

Middle ear surgery is performed on patients for a number of differentreasons, most commonly for chronic recurring ear infections. Whenperforming middle ear surgery, the ear, nose and throat (ENT) surgeon(or “otolaryngologist”) typically visualizes the middle ear and thesurgical procedure in one of two ways. In some cases, the surgeon uses amicroscope, positioned in front of the surgeon's eyes, and she typicallyuses her non-dominant hand to hold a suction device and her dominanthand to hold a surgical tool. In other cases, the surgeon uses ahandheld endoscope to visualize the middle ear. The use of a handheldendoscope is problematic in several different ways.

First, standard endoscopes have long shafts and are not made for use inthe ear. When the ENT surgeon uses an endoscope in the ear, he has tohold the handle of the scope up in the air, over the patient's head,with the surgeon's hand suspended in the air, unsupported. This factoralone is problematic, because if the surgeon accidentally moves hisunsupported hand during surgery, he could very easily move the distalend of the endoscope in a way that could damage the tympanic membrane orone or more of the delicate structures of the middle ear.

Second, compounding on the first issue, endoscopes are generally muchheavier than the small, thin surgical tools used in middle earprocedures. The surgeon thus has an ergonomic imbalance between arelatively heavy endoscope in her non-dominant hand and a relativelylight surgical device in her dominant hand. This imbalance adds to thedifficulty in stabilizing the endoscope. Additionally, holding a heavyendoscope suspended over the patient's head during a surgical proceduremay quickly lead to arm and hand fatigue for the surgeon.

Third, since the surgeon is holding the endoscope in one hand, that handis no longer free to hold a suction device or a surgical tool. Thus,when an endoscope is used for visualization, the surgeon cannot use asuction device and visualize the inside of the ear at the same time.

Fourth, standard endoscopes have straight shafts, so the surgeon musthold the endoscope in a direct line straight back from the patient'sear. This straight-line position makes it impossible, or at leastincredibly challenging, to use an endoscope and a microscope in the samesurgical procedure, since the position of the endoscope is directly inthe path of vision of the microscope. This is a drawback, because insome procedures an ENT surgeon would like to be able to switch back andforth quickly and easily between viewing with a microscope and viewingwith an endoscope. It is also challenging for a surgeon to manipulatemultiple tools with straight shafts held in two hands during an earsurgery procedure, because the hands must be held very close together(due to the small diameter of the ear canal), and the tools tend to bumpinto one another as the surgeon manipulates them to perform theprocedure.

For at least these reasons, it would be advantageous to have an improvedsystem and method for ear visualization. Ideally such a system andmethod would be easy to use, allow for good visualization of the ear,and be compatible with use of other ear surgery devices. At least someof these objectives will be addressed in this disclosure.

BRIEF SUMMARY

This disclosure describes various embodiments of a device and method forvisualizing an ear surgery procedure. In general, the device combines avisualization component (e.g., a camera) with a surgical tool componentvia a sheath that holds the two components together. In someembodiments, the surgical tool is a suction device, and thus thecombined device in those embodiments is used for visualization andsuction. The device is held in one hand and is short enough and thinenough to be advanced easily into the ear and to allow the surgeon torest her hand on the patient's head during the procedure while holdingthe device, which surgeons often do in ear surgery procedures for handstability. In some embodiments, the camera is free to roll (or “spin”)about its own axis within the sheath and/or the camera is free to rotatearound the longitudinal axis of the suction device within the sheath.

In one aspect of the disclosure, a device for visualizing a surgicalprocedure on an ear may include a suction tube, a camera coupled withthe suction tube in a side-by-side arrangement, and a sheath disposedaround an outside of the suction tube and an outside of the camera tocouple the suction tube and the camera together. In some embodiments,the sheath holds the camera and the suction tube in such a way that thecamera is free to roll or spin about its own axis within the sheath, andthe camera is also free to rotate about a longitudinal axis of thesuction tube within the sheath. In some embodiments, the suction tubemay have an outer diameter of no more than about 1.1 millimeters, andthe camera may have an outer diameter of no more than about 2.5millimeters. In some embodiments, for example, the sheath is disposedaround the camera and the suction tube but is not fixedly attached toeither one, so they are free to roll and rotate within the sheath. Forexample, the surgeon may want to roll the camera for image orientationand/or may want to rotate the camera around the suction tube forergonomic reasons, such when moving the device from one hand to theother.

In some embodiments, the suction tube is rigid and includes a tubularportion with a distal suction end, a suction device attachment endopposite the distal suction end, and a bend in the tubular portion. Insome embodiments, for example, the tubular portion is located about40-100 millimeters from the distal suction end. In one embodiment, thebend in the tubular portion forms an angle of about 45 degrees, althoughother angles are possible in alternative embodiments. In someembodiments, the sheath is shorter than a distance from the distalsuction end to the bend in the tubular portion, and the camera and thesheath are configured to slide along the tubular portion of the suctiontube from a first position, in which a distal end of the camera isadjacent the distal suction end of the tubular portion, and a secondposition, in which the distal end of the camera is proximal to thedistal suction end. In some embodiments the suction tube is made ofmetal. In some embodiments, at least a portion of the camera may beflexible. In some embodiments, the sheath is made of a heat-shrinkpolymer.

In another aspect of the disclosure, a method for performing a surgicalprocedure on an ear of a patient involves holding a combinedvisualization and suction device in one hand and advancing a distal endof the combined visualization and suction device into the ear. Thecombined visualization and suction device may be the same as or similarto the one described immediately above, and it may have any or all ofthe features described above. The method also involves viewing using thecamera to view inside of the ear, activating the suction tube inside ofthe ear, and performing the surgical procedure on the ear, using asurgical tool held in the hand that is not holding the combinedvisualization and suction device. The method may also involve using theactivated suction tube of the device to hold and move one or morestructures within the ear. The activated suction tube may alternativelyor additionally be used to suction fluid from the ear.

In some embodiments, the method may further involve rolling the cameraabout its own longitudinal axis within the sheath. The method may alsoinvolve rotating the camera around a longitudinal axis of the suctiontube within the sheath. In some embodiments, the method may involveadditionally viewing the ear using a microscope. Optionally, the suctiontube may include a bend, and the method may further involve holding thecombined visualization and suction device outside of a direct line ofsight between a surgeon's eyes and the ear. The method may also involvesupporting the hand that is holding the combined visualization andsuction device on the patient's head during the surgical procedure.Optionally, the method may involve supporting the hand that is holdingthe surgical tool on the patient's head during the surgical procedure.

In another aspect of the present disclosure, a device for visualizing asurgical procedure in an ear may include an ear endoscope and a coupler.The ear endoscope includes a handle, a shaft extending from the handleand having a bend with an angle of 90-155 degrees, an outer diameter ofno more than 2.5 millimeters, and a length of 30-80 millimeters, animaging sensor at a distal end of the shaft, and a light source. Thecoupler is attached to a side of the ear endoscope shaft for attaching atool to the endoscope. In various embodiments, the surgical tool and theoverall device may include any of the features described above. Thesurgical tool may be a suction device, as previously described, oralternatively it may be any other suitable tool, such as but not limitedto a cutting device, a piercing device, an ear tube placement device, aseeker, tweezers or forceps.

In another aspect of the disclosure, a method for performing a surgicalprocedure in an ear of a patient may first involve attaching a tool toan ear endoscope in a side-by-side arrangement, using a coupler, wherethe ear endoscope includes a shaft with a bend and an outer diameter ofno more than 2.5 millimeters. The method may further involve holding ahandle of the ear endoscope in one hand, advancing a distal end of theear endoscope into the ear with the tool attached, viewing an inside ofthe ear, using the ear endoscope, and using the tool attached to the earendoscope to facilitate or perform at least part of the surgicalprocedure. The combined visualization and surgical tool device may bethe same as, or similar to, the embodiment described above, and it mayinclude any of the features described above.

In another aspect of the present disclosure, an ear endoscope device foruse in a surgical procedure in an ear may include a handle, avisualization shaft extending from the handle, a tool guide extendingfrom the handle parallel to the visualization shaft and configured toguide a tool into the ear with the visualization shaft, an imagingsensor at a distal end of the visualization shaft, and a light source.In one embodiment, the ear endoscope device may include at least onetool coupler on a side of the shaft, at least one suction shaftinsertion port at or near a distal end of the handle, two side suctiontube connection ports at or near the distal end of the handle, a rearsuction tube connection port at or near a proximal end of the handle,and a suction lumen connecting the rear suction tube connection port tothe two side suction tube connection ports. In various embodiments, theshaft and the handle may form an angle of between about 90 degrees andabout 155 degrees. In some embodiments, the shaft may have an outerdiameter of no more than about 2.5 millimeters and a length of betweenabout 30 millimeters and about 80 millimeters.

In some embodiments, the ear endoscope further includes a suctiondevice. The suction device may include a suction shaft for passingthrough the at least one suction shaft insertion port and the at leastone tool coupler, a thumb depress member coupled with the suction shaftfor allowing a user to advance the suction shaft, a side suction tubefor attaching the suction shaft, via the thumb depress portion, to oneof the two side suction tube connection ports, and a rear suction tubefor connecting the rear suction tube connection port to a suctionsource. The suction device may further include a spring disposed over aproximal portion of the suction shaft, between the thumb depress memberand the handle of the ear endoscope. The spring may be configured toautomatically retract the suction shaft relative to the shaft when thethumb depress portion is released. In some embodiments, an open one ofthe two side suction tube connection ports that is not attached to theside suction tube is configured to act as a finger operated suctioncontrol for controlling the application of suction force with a user'sfinger.

In some embodiments, the handle includes two suction shaft insertionports and two tool couplers disposed on opposite sides of the shaft,where each of the two suction shaft insertion ports feeds into acorresponding one of the two tool couplers. In some embodiments, thehandle includes a finger loop for facilitating holding the device with auser's finger under the handle. Alternatively, the handle may includeany other finger hold shape or other ergonomic shape to facilitategripping the device with one hand.

In another aspect of the present disclosure, a method for performing asurgical procedure in an ear canal of a patient may involve holding inone hand an ear endoscope with an attached suction device, advancing adistal end of the ear endoscope with the attached suction device intothe patient's ear canal, depressing a thumb depress member of thesuction device with a thumb of the hand, to advance a suction shaft ofthe suction device relative to a visualization shaft of the earendoscope, applying suction in the ear canal with the suction device,and viewing an inside of the ear canal, using the ear endoscope. In oneembodiment, applying suction in the ear canal involves applying a fingerof the hand to an open suction control opening on the handle.

In some embodiments, the method also involves releasing the thumbdepress portion to allow a spring on the suction shaft to expand tocause the suction shaft to retract relative to the shaft of the earendoscope. In some embodiments, depressing the thumb depress membercauses the suction shaft to advance through a suction shaft insertionport on a handle of the ear endoscope and through a tool couplerattached to the shaft of the ear endoscope. The spring may be disposedover the suction shaft, between the thumb depress member and the handle.The method may optionally also involve supporting the hand that isholding the ear endoscope on the patient's head during the surgicalprocedure.

These and other aspects and embodiments are described in further detailbelow, in relation to the attached drawing figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a surgeon's hands and a surgical field,including a patient's ear, illustrating how a prior art endoscope andsurgical tool are typically held;

FIG. 2 is a side view of an ear visualization system, shown with asuction device, according to one embodiment;

FIG. 3 is a close-up illustration of a distal portion of the earendoscope shown in FIG. 2;

FIG. 4 is a perspective view of coupler for use with an earvisualization system, according to one embodiment;

FIGS. 5A-5C are side views of a combined visualization and suctiondevice for use in ear surgery procedures, according to one embodiment;

FIG. 5D is a front end-on view of the combined visualization and suctiondevice of FIGS. 5A-5C;

FIG. 6 is a perspective view of a surgeon's hands and a surgical field,including a patient's ear, illustrating how a combined visualization andsuction device, according to one embodiment, may be held and used duringan ear surgery procedure; and

FIG. 7 is a side view of a combined visualization and suction device foruse in ear surgery procedures, where the camera has a bend near itsdistal end, according to one embodiment;

FIG. 8 is a side view of a combined visualization and suction device foruse in ear surgery procedures, where the sheath couples the camera andsuction tube together at an angle relative to one another, according toanother embodiment;

FIGS. 9A-9C are side, front and exploded views, respectively, of acombination visualization and suction device, according to oneembodiment;

FIGS. 10A and 10B are side views of a portion of the combination deviceof FIGS. 9A-9C, illustrating a method for advancing and retracting asuction shaft relative to a visualization shaft, according to oneembodiment;

FIG. 11 is a perspective view of a physician's hand holding thecombination device of FIGS. 9A-10B;

FIG. 12 is a perspective view of a visualization component of thecombination device of FIGS. 9A-11, along with a viewing system,according to one embodiment;

FIGS. 13A-13C are right perspective, left perspective and left sideviews, respectively, of an ear endoscope device, according to oneembodiment;

FIG. 14A is a side view of the ear endoscope device of FIGS. 13A-13C,with a detached optional suction device for the endoscope, according toone embodiment;

FIG. 14B is a side view of the ear endoscope and suction device of FIG.14A, with the suction device attached;

FIG. 14C is a perspective view of the ear endoscope with attachedsuction device of FIG. 14B, shown in the left hand of a physician user;

FIG. 15 is a distal-end view of a shaft of an ear endoscope, accordingto an alternative embodiment.

DETAILED DESCRIPTION

In general, the embodiments described herein are directed to a device,system and method for visualizing an ear surgery procedure. The earvisualization device generally includes an ear endoscope (or “camera”),with an attachment mechanism for attaching an additional tool to theendoscope. Oftentimes, the additional tool is a suction device, but thisis not a requirement, and in alternative embodiments, any of a number ofdifferent tools may be attached to the endoscope. In some embodiments,the attachment mechanism is built into the endoscope. Alternatively, theattachment mechanism may be a separate coupler or sheath, which attachesto the shaft of the ear endoscope and allows any of a number ofdifferent types of surgical tools to be attached to the endoscope in aside-by-side arrangement. The ear visualization system may include theear endoscope along with a separate attachment mechanism, a light sourcefor the endoscope, a video monitor for displaying images captured by theendoscope and/or any other suitable components. In some embodiments, thesystem may also include a suction device or other surgical tool. Inother embodiments, the ear endoscope device or system may be provided byitself, and may be used with one or more optional, stand-alone tools.

As mentioned immediately above, in some embodiments, the attachmentmechanism is a separate piece, which may be removed from the endoscopeshaft. In such embodiments, the endoscope and the coupler may bereferred to as a “system,” due to the combination of two differentdevices. In alternative embodiments, the coupler may be integral with,or permanently attached to, the endoscope shaft, in which case theendoscope with coupler may be referred to as a “device.” In any case,use of the terms “system” and “device” herein should not be interpretedas limiting the scope of the invention.

The shaft of the ear endoscope and whatever surgical tool it is usedwith may have very small diameters, so the distal end of the combineddevice fits easily into an ear canal, for helping visualize and performan ear surgery procedure. In some embodiments, the coupler surroundspart of the endoscope shaft and part of the surgical tool in such a waythat the shaft can rotate about a longitudinal axis of the tool and canalso roll (or “spin”) about its own longitudinal axis.

In one embodiment, described in detail below, the surgical tool is asuction tube device. In alternative embodiments, however, the tool maybe any suitable, small-diameter tool, such as but not limited to acutting device, a piercing device, an ear tube placement device, aseeker, tweezers, forceps, a speculum, a grasper, or a curette. In thedescription below of the suction embodiment, the fact that any othersuitably sized surgical tool may be substituted for the suction devicewill not be repeated with the description of every embodiment.Similarly, the devices and methods described below for use in an earsurgery procedure may be used or adapted for use in any other suitablesurgical procedure. This, too, will not be repeated with the descriptionof every embodiment.

Although the following description is focused on use of the devices,systems and methods for visualizing and facilitating ear surgeryprocedures, the same embodiments may be used, or adapted for use, in anyother suitable procedures and parts of a human or animal body.Therefore, the invention is not limited to use in the ear.

Referring now to FIG. 1, a prior art method for performing an earsurgery using a standard endoscope 10 is illustrated. The figure shows asurgical field, with the patient's ear E exposed for the procedure. Thesurgeon is holding the endoscope 10 in his left hand L and a surgicaltool 12 in his right hand. Due to the length of the endoscope 10, thesurgeon has to hold his left hand L up in the air, suspended over thepatient, in order to hold the handle of the endoscope 10. As mentionedpreviously, this can be very awkward and potentially dangerous to thetympanic membrane and/or structures of the middle ear, especially inlonger procedures where the surgeon's left arm and left hand L getfatigued. Additionally, the surgeon does not have a free hand to hold asuction device or other surgical tool, since both of the surgeon's handsare occupied. To have suction in this scenario, a nurse or otherassistant would have to hold the suction device in the patient's ear.

Referring to FIG. 2, an ear surgery visualization system 100, accordingto one embodiment, may include an ear endoscope 102 and a coupler 112.Also pictured in FIG. 2 is a suction device 128, which is notnecessarily part of the system 100, but which is shown in the figure forillustrative purposes. In alternative embodiments, the suction device128 may be replaced by any other suitable surgical tool, such as theones listed previously.

The ear endoscope 102 includes a handle 104, a shaft 106 and a processor122, which may also act as a light source. The shaft 106 includes aproximal portion 107, a bend 108 and a distal portion 110, ending in adistal tip 111. The endoscope 102 also includes a light source 120 inthe handle 104, and light fibers 118 that carry the light from the lightsource 120, through the shaft 106, to the distal tip 111. A camera on achip (described more fully below) may be positioned at the distal tip111, to acquire images of the ear. The system 100 may also include avideo monitor 126, although optionally the video monitor 126 may be aseparate component that is not part of the system 100. In anotherembodiment, the processor 122 and video monitor 126 may be combined inone unit.

The shaft 106 of the endoscope 102 may have a total length of about 30millimeters to about 80 millimeters and an outer diameter of less thanabout 2.5 millimeters. In some embodiments, the outer diameter of theshaft 106 may be continuous along its length. Alternatively, the outerdiameter of the distal portion 110 may be smaller than the outerdiameter of the proximal portion 107. The bend 108 may form an anglebetween the proximal portion 107 and the distal portion 110 of betweenabout 90 degrees and about 155 degrees. The handle 104 may be very smalland lightweight, compared to typical endoscope handles. In fact, thehandle 104 may be shaped to have a comfortable pencil grip, so thesurgeon may hold and manipulate the ear endoscope 102 like a pencil. Earendoscope 102 may also include a cable 124, attaching the handle 104 tothe processor 122.

The coupler 112 includes an endoscope attachment portion 114 and a toolattachment portion 116. In some embodiments, each of the two portions114, 116 is shaped as a tube or a semicircular tube. In someembodiments, the endoscope attachment portion 114 and the toolattachment portion 116 may have the same diameter. Alternatively, theymay have different diameters. For example, in some embodiments theendoscope attachment portion 114 has a larger diameter than that of thetool attachment portion 116. The coupler 112 may be permanently attachedto the shaft 106, or it may be removable, according to differentalternative embodiments. The coupler 112 may be attached to the distalportion 110 of the shaft 106, as shown. Alternatively, the coupler 112may be attached to the proximal portion 107, for example if the shaft106 is straight, or of the coupler 112 follows the bend 108 in the shaft106.

The weight, size and feel of the ear endoscope 102 may be similar tothat of other ear surgery tools. This makes it more comfortable for thesurgeon to hold and prevents an imbalance between the ear endoscope 102and other tools. The surgeon may hold the handle 104 with a pencil gripand may rest her hand and/or the handle 104 on the patient's head duringthe procedure. In order to achieve this desired weight, size and feel,any suitable materials may be used for the various parts of the earvisualization system 100. For example, in one embodiment, the handle 104may be made of any suitable lightweight plastic, and the shaft 106 maybe made of any suitable metal, such as stainless steel. Alternatively,the handle 104 may be made of a lightweight metal. The coupler 112 maybe made of plastic or metal, for example. Any suitable, medically safematerials may be used.

As mentioned above, a suction device 128 is illustrated in FIG. 2,attached to the shaft 106 of the endoscope 102 via the coupler 112, in aside-by-side arrangement. Any other tool may be substituted for thesuction device 128, in alternative embodiments. The suction device 128is also shown with a source of suction 130, which may be a separatecomponent, wall suction, or any suitable suction source. The suctiontube portion of the suction device 128 is flexible, at least along partof its length, and has a distal portion with an outer diameter that fitswithin the tool attachment portion 116 of the coupler. Variousembodiments and features of a suction device 128 are described infurther detail below.

Referring now to FIG. 3, the distal portion 110 of the endoscope shaft106 is illustrated in greater detail. At the distal end 111 of the shaft106 are positioned an imaging sensor 140 and two light sources 142. Theimaging sensor 140 may be any type of suitable sensor, such as acomplementary metal-oxide semiconductor (CMOS) camera or any other“camera on a chip” type of device. The two light sources 142 (oralternatively any other number of light sources) may be light emittingdiode (LED) lights, for example. These may be in addition to, or as analternative to, the light source 120 shown in the handle 104 in FIG. 2.In other words, according to various embodiments, one or more lightsources for the endoscope device 102 may be located in the handle 104,at the distal end 111 of the shaft 106, or both.

FIG. 4 is a magnified view of an alternative embodiment of a coupler 212for use with the ear endoscope 102. The coupler 212 includes anendoscope attachment portion 214, a tool attachment portion 216, alongitudinal top opening 250 in the tool attachment portion 216, and alongitudinal middle opening 252 between the endoscope attachment portion214 and the tool attachment portion 216. In this embodiment theendoscope attachment portion 214 has a larger diameter than that of thetool attachment portion 216. The tool (not shown) may be inserted intothe tool attachment portion 216 by pushing it down through the topopening 250 or by sliding it into the proximal end of the toolattachment portion 216 and advancing it distally. In the case where thetool is pushed through the top opening 250, the coupler 212 may flexoutward slightly, by expanding at the two openings 250, 252, toaccommodate the tool. In alternative embodiments, the endoscopeattachment portion 214 and/or the tool attachment portion 216 may beformed as complete tubes, with circular cross-sections rather thansemi-circular cross-sections. As mentioned above, the coupler may bemade of any suitable material.

Referring to FIGS. 5A-5D, one embodiment of an ear surgery visualizationdevice 20 is illustrated. In this embodiment, the visualization device20, which may also be called “a combined visualization and suctiondevice,” includes a suction tube 22, a camera 30 and a coupler 38 (or“sheath”) disposed around the suction tube 22 and the camera 30. Thesuction tube 22 has a distal end 24, a proximal end 26 for connectingwith suction tubing connected to a suction source, and a bend 28 alongits length. The camera 30 includes a distal portion 32, a proximalportion 36 and a distal end 34.

The suction tube 22 may be any standard or customized suction tubedevice. In various embodiments, the suction tube 22 may be rigid and maybe made out of any suitable material, such as stainless steel or otherbiocompatible metal or plastic. The suction tube 22 will have an overalldiameter and length to allow it to be advanced easily into the ear andto allow a surgeon to hold the visualization device 20 with one hand,resting on the patient's head, during the procedure. In someembodiments, for example, the suction tube 22 has an outer diameter, atleast along the portion between the bend 28 and the distal end 24, ofabout 0.6 millimeter to about 1.1 millimeters. The bend 28 in thesuction tube 22 is optional, and alternative embodiments may bestraight. The bend 28 may be advantageous, however, because it allowsthe visualization device 20 to be held at an angle from the ear, so thehand holding the device 20 is not in the direct line of sight of thesurgeon. This is especially advantageous in cases where the surgeonwants to use a microscope and the visualization device 20 in the sameprocedure, but it is also advantageous in keeping the suction tube 22and the camera 30 out of the way of any surgical tools held in thesurgeon's other hand. In various embodiments, for example, the bend 28may be located about 40 millimeters to about 100 millimeters from thedistal end 24 of the suction tube 22. In one embodiment, the bend may beabout 60 millimeters from the distal end 24. In alternative embodimentsof the device 20, where the camera 30 is combined with a different typeof surgical tool rather than the suction tube 22, that surgical tool mayalso include the same or a similar bend.

The camera 30 may be any suitable, small-diameter camera for viewing anear during an ear surgery procedure. In some embodiments, for example,the camera 30 may be a fiber optic camera or a complementarymetal—oxide—semiconductor (CMOS) camera. As small-diameter cameras arewell known, they will not be described in detail here. In someembodiments, at least the distal portion 32 of the camera 30 may berelatively rigid, so that the surgeon can easily roll it about itslongitudinal axis and/or rotate it relative to the suction tube 22. Insome embodiments, the camera 30 may include a bend, which may coincidewith the bend 28 in the suction tube. The camera 30 may include CMOSsensors with a lens array. The sensors may be arrayed in a cube ofbetween 0.6 mm by 0.6 mm and 1.0 mm by 1.0 mm, with overall length of upto 3 mm, in some examples. Alternative embodiments may include a fiberoptic bundle for image capture, rather than CMOS. The light source forillumination may be LED at the distal tip 34 or fiber infused with lightfrom a remote LED.

The cross-sectional shape of the camera 30 may vary in differentembodiments (round, oval, square, rectangular, etc.), but in theembodiment shown the camera 30 has a round cross-sectional shape. Thisis advantageous for rolling and rotating the camera 30 within thecoupler 38 and relative to the suction tube 22. The body of the camera30 is made from a relatively rigid or at least semi-rigid material, suchas stainless steel or plastic (e.g., thermoplastic). The length of thedistal portion 32 may be, for example, about 5 mm to about 100 mm. Insome embodiments, the distal portion 32 may be as long as the length ofthe suction tube 22 from its distal end 24 to the bend 28, which in oneembodiment is about 60 mm. In various embodiments, the camera 30 and alight source may be integrated into a metal tube, over-molded withplastic, encapsulated in a polymer, or the like.

The coupler 38 may be any suitable material and have any suitablelength, thickness and size, according to various embodiments. In oneembodiment, the coupler 38 is formed as a tube of heat-shrink polymerwrap that surrounds distal portions of the suction tube 22 and thecamera 30. The heat-shrink polymer may be polyethylene terephthalate(PET) in some embodiments, or may alternatively be any other suitablepolymer, such as but not limited to a polyolefin, a polyimide or nylon.As illustrated in FIGS. 5A and 5B, in one embodiment, the coupler 38 isdisposed about the suction tube and the camera 30 such that the suctiontube 22 can advance (FIG. 5B) and retract (FIG. 5A), relative to thecoupler 38 and the camera 30. For example, in some embodiments, thesuction tube 22 can advance from a position where its distal end 24 isat or near the distal end 34 of the camera 30 (FIG. 5A) to a positionwhere its distal end 24 is ahead of that of the camera 30 (FIG. 5B). Inthis embodiment, the camera 30 may also be able to slide forward andbackward. In alternative embodiments, camera 30, suction tube 22 or bothmay be fixed to the inner surface of the coupler 38, such as byadhesive, thus reducing the amount of mobility of one or both componentsrelative to the coupler 38.

FIG. 5C is an exploded view of the ear surgery visualization device 20,showing the suction tube 22, the camera 30 and the coupler 38 separatefrom one another. For assembly, the coupler 38 may be wrapped or slidover the suction tube 22 and the camera 30 in some embodiments.

FIG. 5D illustrates possible directions of movement of the camera 30,the suction tube 22 and the coupler 38, relative to one another. In someembodiments, the coupler 38 may be positioned around but not fixedlyattached to the camera 30 and the suction tube 22, as described above.In addition to allowing the suction tube 22 and/or the camera 30 toadvance longitudinally through the coupler 38, this configuration alsoallows the suction tube 22 and the camera 30 to roll about their ownaxes within the coupler 38 (two small hollow arrows around perimeter ofcoupler 38). Additionally, the camera 30 may be rotated around alongitudinal axis of the suction tube 22 (larger hollow arrow). Thesuction tube 22 may also be rotated around a longitudinal axis of thecamera 30. This freedom of movement—rotation and rolling—allow thesurgeon to adjust the orientation of the camera 30 and/or the suctiontube 22 easily and quickly, without necessarily changing the orientationof both components. Again, however, in alternative embodiments thecoupler 38 may be adhered or otherwise fixedly attached to either orboth of the camera 30 and the suction tube 22.

FIG. 6 shows a surgical field, including a patient's ear E, and the lefthand L and the right hand R of a surgeon, performing a procedure on theear E. The surgeon's left hand L is holding the ear surgeryvisualization device 20, as described above, which includes the suctiontube 22 and the camera 30. The suction tube 22 is attached proximally toa suction hose 40, which in turn is attached to a source of suction (notshown). The surgeon's right hand R holds a surgical tool 12. Asindicated by the large arrows on the figure, the surgeon's hands areapproaching the ear E from two different angles, leaving a line ofdirect vision open from the surgeon's eyes to the patient's ear E(depicted by the middle/upper-right hollow arrow). This arrangement willallow a surgeon to visualize the surgical field using both a microscopeand the camera 30, if desired. As also illustrated in FIG. 6, the earvisualization device 20 is sized and shaped such that the surgeon canrest her hand on the patient's head during the procedure. In performingthe procedure, the surgeon may advance the device 20 into the ear E,suction out the ear E using the suction tube 22, visualize the ear Eusing the camera 30, and perform the procedure. Alternatively oradditionally, the suction tube 22 may be used to hold onto and move oneor more small anatomical structures of the ear, such as but not limitedto the bones of the middle ear. Suction may also be used to holddifferent devices, such as an ear tube or ossicular prostheses. Thedevice 20 is generally small enough that the camera 30 can be used tovisualize the middle ear through a natural hole or incision in thetympanic membrane. These actions may be performed in any sequence and inany combination. In some embodiments, it may be possible for the surgeonto separate the camera 30 from the suction tube 22 during the earsurgery procedure, so they can be used separately.

In some embodiments, the ear surgery visualization device 20 may be usedwith another, different ear surgery visualization device (not shown).For example, the combined camera/suction tube device 20 may be held inthe surgeon's non-dominant hand, and a combined camera/surgical tooldevice may be held in the surgeon's dominant hand. These two devices 20may be used at the same time, thus acquiring two images of the ear. Theviews from the two cameras may be displayed on a single, split videoscreen, for example, with the right half marked ‘R’ and the left halfmarked ‘L’. In all embodiments, the video screen may be separate andlocated above the patient's head and within the field of view of amicroscope, so that the surgeon can view the surgical field through themicroscope and look at the endoscopic view through the microscope aswell, or simply switch from looking through the microscope to looking atthe video screen. In another embodiment, it may be possible to digitallyfeed the endoscopic image into the microscope, so that the surgeon canview both of them through the microscope, or toggle between them bypressing a button, for example.

Referring now to FIG. 7, an alternative embodiment of an ear surgeryvisualization/suction device 50 is illustrated. As mentioned above, insome embodiments, the suction tube 22 may be advanced, relative to thecamera 30, as shown in FIG. 5B, such that the distal end 24 of thesuction tube 22 is ahead of the distal end 34 of the camera 30. Inembodiments where the distal portions of the suction tube 22 and thecamera 30 are both straight and are connected in parallel with oneanother, the suction tube 22 may interfere with the field of view of thecamera 30 in this configuration. The embodiment of the device 50 shownin FIG. 7 is configured to address that issue. In this embodiment, thedistal portion 32 of the camera 30 includes a bend 52. This bend 52orients the field of view 54 of the camera 30 at an angle, relative tothe longitudinal axes of the suction tube 22 and the camera 30, so thesuction tube 22 does not interfere with or limit the field of view 54.In various embodiments, the bend 52 may be located anywhere along thelength of the camera 30, although in many embodiments it will be locatednear the distal end 34, so that it is distal to the distal end of thecoupler 38.

Referring now to FIG. 8, another alternative embodiment of an earsurgery visualization/suction device 60 is illustrated. This embodimentis alternative way of addressing the issue of the suction tube 22cutting off part of the field of view 54 of the camera. In thisembodiment, the sheath 68 has a wider distal end 64 and a narrowerproximal end 66. Thus, the sheath 68 couples the camera 30 and thesuction tube 22 together such that they are oriented at an anglerelative to one another. In other words, they are not parallel with oneanother. As with the previous embodiment, this helps prevent the fieldof view 54 of the camera 30 from being limited by the suction tube 22.

Referring now to FIGS. 9A-9C, one embodiment of an ear visualizationsystem 300 is illustrated. The ear visualization system 300 includes anear endoscope 302 and an optional suction device 310. The ear endoscope302 includes a handle 304, a shaft 306 extending from one end of thehandle 304, two tool couplers 307 a, 307 b (see FIG. 9B) on either sideof the shaft 306, and a cable 308 extending from the opposite end of thehandle 304. Imaging components pass through the handle 304, the shaft306 and the cable 308, which components may be any of those describedabove and which are not shown in these figures. The handle 304 includestwo suction shaft apertures 305 a, 305 b (not visible in these drawings,because they are on the top surface of the handle 304), through whichthe shaft 316 of the suction component 310 is advanced. The shaft 316 ofthe suction component 310 advances through one of the two tool couplers307 a, 307 b, after exiting the distal end of the corresponding aperture305 a, 305 b. The handle 304 may have any of a number of suitable sizes,shapes and weights, but in this embodiment it is configured to be heldeasily in a pencil grip by the physician. The handle 304 may be made oflightweight plastic, in some embodiments.

The suction component 310 includes a suction tube 312, a thumb depressportion 314, a suction control aperture 320, a suction shaft 316 with adistal end 317, and a spring 318 disposed over the suction shaft 316,between the thumb depress portion 314 and the handle 304. The suctionshaft 316 extends through the suction shaft aperture 305 a in the handle304, through the tool coupler 307 a, and alongside the visualizationcomponent shaft 306. As will be described further below, the userphysician may depress the thumb depress portion 314 to advance thedistal end 317 of the suction shaft 316 out of the distal end of thevisualization shaft 306 and thus farther into the ear. When the userreleases the thumb depress portion 314, the spring 318 automaticallyretracts the suction shaft 316 back along the visualization shaft 306,through the tool coupler 307 a and the aperture 305 a. The physician mayuse an index finger (or other finger) to cover the suction controlaperture 320 to apply suction, and she may remove the finger from thehole to remove or reduce suction at the distal end 317 of the suctionshaft 316.

FIG. 9B is a front view of the ear visualization system 300, whichillustrates that this embodiment includes two suction tool couplers 307a, 307 b, one on either side of the visualization component shaft 306.This embodiment thus also includes two suction shaft apertures 305 a,305 b, each feeding into one of the two suction tool couplers 307 a, 307b. The two tool couplers 307 a, 307 b facilitate holding andmanipulation of the device 300 by either a right hand or a left hand,and placement of the suction tube/other tool either below or above thecamera sensor. The visualization component shaft 306, the tool couplers307 a, 307 b and the suction shaft 316, in some embodiments, may be madeof metal, such as stainless steel or other biocompatible metal. In someembodiments, the visualization component shaft 306 has an outer diameterof about 2.5 millimeters or less. Similarly, each of the tool couplers307 a, 307 b may have an outer diameter of about 2.5 millimeters orless. The suction shaft 316 has an outer diameter sized to fit throughthe inner diameter of the tool couplers 307 a, 307 b. In someembodiments, the suction shaft 316 may have an outer diameter of about1.1 millimeters or less.

FIG. 9C is a side view of the ear visualization system 300, with earendoscope 302 separated from the suction device 310. In this embodiment,the ergonomic design of the handle 304 may be important for facilitatinghandling of the system 300 by the physician. For example, the handle 304includes a finger grip feature 322, which may allow for easy gripping ofthe handle 304 with a middle finger (or other finger). The user's indexfinger may be used to control the suction control aperture 320, and theuser's thumb may be used to control the thumb depress portion 314 of thesuction component 310. In other embodiments, one of which is describedbelow, the finger grip feature 322 may include a loop, an elastic ringor any other suitable shape.

In various alternative embodiments, one or more variations may be madeto the ear endoscope device 300. For example, in some embodiments, thecouplers 307 a, 307 b may extend the entire length (or along a longerportion but not the entire length) of the endoscope main shaft 306. Insome embodiments, there may be only one coupler and one aperture, ratherthan two couplers 307 a, 307 b and two apertures 305 a, 305 b.

Referring to FIG. 15, in yet another alternative embodiment, an earendoscope shaft 500 may include an outer shaft body 502, a tool guide504 forming a tool lumen 506, two light sources 508 a, 508 b and animaging sensor. The tool guide 504 and tool lumen 506, in thisembodiment, are located inside the outer shaft body 502, unlike thepreviously described embodiments that place the suction tube through acoupler on the outside of the main endoscope shaft. In some embodiments,the tool guide 504 may be used for applying suction or advancing asuction device through the shaft 500. Alternatively, the tool guide 504may be used for advancing any other suitable tool through the earendoscope shaft 500, such as any tool listed in this application. Thisembodiment of FIG. 15 may be applied to any of endoscope embodimentsdescribed above or below to generate alternative embodiments.

FIGS. 10A and 10B illustrate a method for advancing and retracting thesuction shaft 316 in the ear visualization system 300, according to oneembodiment. In FIG. 10A, the physician is depressing the thumb depressportion 314 of the suction component 310 with her thumb T. This advancesthe suction shaft 316 through the handle 304 and the tool coupler 307 a,thus advancing the suction shaft 316 along the side of the visualizationshaft 306. Thus, the distal end 317 of the suction shaft 316 would beadvanced farther down into the patient's ear. In this configuration, thespring 318 is compressed. In FIG. 10B, the physician has released herthumb T from the thumb depress portion 314, allowing the spring 318 toexpand and causing the suction shaft 316 to retract proximally throughthe tool coupler 307 a and the handle 304. Thus, the physician caneasily adjust the position of the distal end 317 of the suction shaft316 relative to the visualization shaft 306.

In various embodiments, the distal end 317 of the suction shaft 316 maybe positioned in a number of different locations relative to the distalend of the visualization shaft 306. When the suction shaft 316 is fullyadvanced, its distal end 317 may be located at, proximal to or distal tothe distal end of the visualization shaft 306. Similarly, when thesuction shaft 316 is fully retracted, its distal end 317 may be locatedat, proximal to or distal to the distal end of the visualization shaft306. For example, in one embodiment, the distal end 317 of the suctionshaft 316 may be disposed even with the distal end of the visualizationshaft 306 in the fully retracted position and then may be advanced to aposition distally beyond the distal end of the visualization shaft 306.In another embodiment, the distal end 317 of the suction shaft 316 maybe disposed more proximally than the distal end of the visualizationshaft 306 in the fully retracted position and then may be advanced to aposition even with the distal end of the visualization shaft 306. Anycombination of locations is possible, according to various alternativeembodiments.

Referring to FIG. 11, a physician's hand H is shown holding thecombination device 300 over an anatomical model. As shown, the handle304 fits comfortably in the hand H, with the middle finger on the bottomand the index finger on the top. The thumb is positioned on the thumbdepress portion 314, and the visualization component shaft 306 and thesuction shaft 316 are extended into the model. During an ear procedure,the physician might rest his or her hand on the patient's head, forsupport and stability and to prevent arm fatigue. The very light weightof the handle 304 and the device 300 in general make it easy tomanipulate and hold.

Referring now to FIG. 12, in some embodiments, the ear visualizationsystem 300 may include the ear endoscope 302 and a viewing system 330.The viewing system may include a video monitor 336, a console 332 and acable 334 connecting the two. The console 332 may include a connector338, into which a connector 337 on the visualization component 302inserts. The various parts of the viewing system 330 may be any suitableoff-the-shelf or custom components, according to various embodiments. Inan alternative embodiment, the console 332 may include a built-inscreen, rather than having a separate video monitor 336, and theendoscope 300 would connect to the console 332. In various embodiments,the ear endoscope 302 may be provided with the viewing system 330, withthe suction device 310 or as a stand-alone device.

Referring now to FIGS. 13A-13C, another embodiment of an ear endoscope400 is illustrated. In this embodiment the ear endoscope 400 includes ahandle 402 with a finger loop 404, a shaft 406, two tool coupling shafts408 a, 408 b, two side suction tube connection ports 410 a, 410 b, twosuction tube insertion ports 412 a, 412 b, a rear suction tubeconnection port 414 and a sensor interface cable 416. In thisembodiment, the ear endoscope 400 may be provided as a separate unit andmay be used with an add-on suction device, or it may be provided withthe suction device. In either case, a suction supply may be connected tothe rear suction tube connection port 414, which is in fluidcommunication with a suction lumen running through the handle 402 andexiting at the two side suction tube connection ports 410 a, 410 b. Oneof the two side suction tube connection ports 410 a, 410 b may in turnbe connected to a short suction tube, which is connected to a suctionshaft that passes through one of the suction tube insertion ports 412 a,412 b and one of the tool coupling shafts 408 a, 408 b, as will bedescribed further below. Whichever of the two suction tube connectionports 410 a, 410 b that is left open may be used by the physician as asuction control, by placing a finger over, or releasing the finger from,the port 410 a, 410 b. The finger loop 404 on the handle 402 may beflexible in some embodiments and rigid in others. In alternativeembodiments, it may have any other suitable shape or size forfacilitating gripping the endoscope 400. As is evident from FIGS.13A-13C, the shaft 406 is straight in this embodiment, but it is angledrelative to the handle 402, so that the overall endoscope device 400 isangled, to allow the physician to place the shaft 406 in the ear canalwithout obstructing a direct viewing path into the ear canal.

Referring now to FIGS. 14A-14C, the ear endoscope of FIGS. 13A-13C isnow shown with an optional suction device 420. FIG. 14A shows thesuction device 420 detached from the ear endoscope 400. The suctiondevice 420 includes a suction shaft 422, connected to a thumb depressmember 424, connected to a side suction tube 426, and it also includes arear suction tube 428. The suction shaft 422 is passed through either ofthe two suction tube insertion ports 412 a, 412 b and thus through thecorresponding tool coupling shaft 408 a, 408 b. Side suction tube 426may be connected to either of the two side suction tube connection ports410 a, 410 b, leaving the opposite side port 410 a, 410 b open forfinger control of suction. Additionally, the rear suction tube 428 isattached to the rear suction tube connection port 414, to supply suctionforce from a suction supply (not shown) to the suction device 420. Asexplained above, a suction lumen in the handle 402 of the endoscope 400(not visible in the figures) connects the rear suction tube connectionport 414 with the two side suction tube connection ports 410 a, 410 b.

FIG. 14B shows all the components of the suction device 420 attached tothe ear endoscope. FIG. 14C shows a physician's left hand H holding thecombined ear endoscope 400 and suction device. As illustrated here, thephysician's thumb is positioned on the thumb depress member 424 and isused to advance the suction shaft 422. The physician's middle or ringfinger may be placed through the finger loop 404 of the handle 402. Andthe physician's index finger may be placed over or removed from the openside suction tube connection port 410 b, to control the application ofsuction through the suction shaft 422. If the physician prefers to holdthe ear endoscope 400 in his right hand, the side suction tube 426 andsuction shaft 422 may simply be shifted to the opposite side of the earendoscope 400.

FIG. 15 is a cross-sectional view of a distal/shaft portion of an earvisualization device 500, according to one embodiment. The portion ofthe device 500 illustrated in FIG. 15 may be used with any of theembodiments described above or below. The illustrated portion of thedevice 500 includes an outer shaft 502, inside of which there is asuction shaft 504 forming a suction lumen 506. Also located inside theouter shaft 502 are a camera 510 and two sets of light fibers 508 a, 508b, which are illustrated as rectangular but may be bundled in circular,ovoid or any other suitable shapes. In some embodiments, the inside ofthe outer shaft 502 may be solid or filled with a material, and thecamera 510 and light fibers 508 a, 508 b may reside in lumens formedwithin the material in the outer shaft 502. Again, this is only oneexemplary embodiment of the shaft portion of a device 500.

The above description of embodiments and features of various devices andmethods is believed to be complete. The embodiments are meant toexemplary in nature, however, and not exhaustive. Thus, theirdescription should not be interpreted as limiting the scope of theinvention.

We claim:
 1. A device for visualizing and providing suction during asurgical procedure in an ear, the device comprising: a handlecomprising: at least one suction tube insertion port on a top surface ofthe handle; and a rear suction connection port; a visualization shaftextending from the handle at an angle relative to a longitudinal axis ofthe handle; at least one tool coupling shaft extending from the handlealong a first side of the visualization shaft and in fluid communicationwith the at least one suction tube insertion port; an imaging sensor ata distal end of the visualization shaft; a light source; a suction shaftremovably coupled with the handle and comprising a distal end sized toslide through the at least one suction tube insertion port and the atleast one tool coupling shaft; a spring disposed over a proximal portionof the suction shaft to automatically retract the suction shaft whenforce applied to a proximal end of the suction shaft is released; atleast one side suction tube port on a side of the handle; and a sidesuction tube removably attached at a first end to the at least one sidesuction tube port and at a second end to the suction shaft at or nearthe proximal end.
 2. The device of claim 1, further comprising: amonitor coupled with the handle; and a processing unit coupled with thehandle.
 3. The device of claim 2, wherein the monitor and the processingunit are housed in one device coupled with the handle via a cable. 4.The device of claim 1, wherein the at least one suction tube insertionport comprises two suction tube insertion ports, the at least one toolcoupling shaft comprises two tool coupling shafts on opposite sides ofthe visualization shaft, and the at least one side suction tube portcomprises two side suction tube ports on opposite sides of the handle.5. The device of claim 4, further comprising an additional toolconfigured to be advanced through either of the two suction tubeinsertion ports and the two tool coupling shafts.
 6. The device of claim1, further comprising a thumb depress member coupled with the proximalend of the suction shaft, wherein the spring is disposed over theproximal portion of the suction shaft, between the top surface of thehandle and the thumb depress member.
 7. The device of claim 1, whereinthe suction shaft has an outer diameter of no more than 1.1 millimeters,and wherein the visualization shaft has an outer diameter of no morethan 2.5 millimeters.
 8. The device of claim 1, further comprising afinger loop on the handle configured to allow the handle to be held witha single finger.
 9. The device of claim 1, wherein the at least onesuction tube insertion port comprises a right suction tube insertionport and a left suction tube insertion port, and wherein the at leastone tool coupling shaft comprises a right tool coupling shaft in fluidcommunication with the right suction tube insertion port and a left toolcoupling shaft in fluid communication with the left suction tubeinsertion port.
 10. An ear endoscope device for use in a surgicalprocedure in an ear, the device comprising: a handle comprising: a rightsuction tube insertion port on a top surface of the handle; a leftsuction tube insertion port on the top surface; and a rear suctionconnection port; a visualization shaft extending from the handle at anangle relative to a longitudinal axis of the handle; a right tool guideextending from the handle along a right side of the visualization shaft,in fluid communication with the right suction tube insertion port; aleft tool guide extending from the handle along a left side of thevisualization shaft, in fluid communication with the left suction tubeinsertion port; an imaging sensor at a distal end of the visualizationshaft; a light source; a suction shaft removably coupled with thehandle, the suction shaft comprising a distal end sized to slide throughthe right and left suction tube insertion ports and the right and lefttool guides; a spring disposed over a proximal portion of the suctionshaft to automatically retract the suction shaft when force applied to aproximal end of the suction shaft is released a right side suction tubeport on a right side of the handle; a left side suction tube port on aleft side of the handle; and a side suction tube removably attached at afirst end to the right side suction tube port or the left side suctiontube port and at a second end to the suction shaft at or near theproximal end, wherein the right side suction tube port or the left sidesuction tube port, when not attached to the side suction tube, isconfigured to be covered by a finger to apply suction via the suctionshaft.
 11. The device of claim 10, further comprising a suction lumen inthe handle, connecting the rear suction connection port to the rightside suction tube port and the left side suction tube port.
 12. Thedevice of claim 10, wherein the visualization shaft and the handle forman angle of 90-155 degrees.
 13. The device of claim 10, wherein thevisualization shaft has an outer diameter of no more than 2.5millimeters and a length of 30-80 millimeters.
 14. The device of claim10, further comprising: a thumb depress member coupled with the proximalend of the suction shaft for allowing a user to advance the suctionshaft and further coupled with a first end of the side suction tube. 15.The device of claim 14, wherein the spring is disposed over a proximalportion of the suction shaft, between the thumb depress member and thetop of the handle, wherein the spring is configured to automaticallyretract the suction shaft relative to the visualization shaft when thethumb depress portion is released.
 16. The device of claim 10, whereinthe handle comprises a finger loop for facilitating holding the devicewith a single finger under the handle.
 17. The device of claim 10,further comprising an additional tool configured to be advanced througheither of the right and left suction tube insertion ports.